Inflation and monitoring assembly for a pressure cuff

ABSTRACT

An assembly structured to inflate a retaining or pressure cuff of a medical device of the type associated with artificial airway tube and concurrently monitor pressure therein. A pump assembly is movably connected to a casing and structured to force fluid flow, for inflation of a pressure chamber of the casing. An indicator member is visually accessible through a casing window and is variably positionable dependent on and indicative of existing pressure within the retaining cuff. The existing pressure within the pressure chamber is substantially equivalent to that within the retaining cuff thereby facilitating the variable position of the indicator member being indicative of pressure within the retaining cuff. A junction between the casing and an inflation lumen is structured to allow disconnection and prevent reconnection between the casing and the lumen.

CLAIM OF PRIORITY

The present application is a continuation-in-part application ofpreviously filed, now pending application having Ser. No. 13/005,359,filed on Jan. 12, 2011, which is a continuation-in-part application ofpreviously filed, now pending application having Ser. No. 12/806,810,filed on Aug. 20, 2010, which is a continuation-in-part application ofpreviously filed, now pending application having Ser. No. 12/661,103,filed on Mar. 10, 2010 all of which are incorporated herein by referencein their entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention is directed to an assembly structured to inflate andcontinuously monitor pressure within an inflatable cuff, such as aretaining cuff for an endotracheal tube and/or tracheostomy tube. Acasing and a pump assembly are collectively operative to inflate thecuff and monitor existing pressure therein. The casing may bealternately structured for fixed or removable securement to either orboth the pump assembly and an inflating lumen communicating with thecuff. Moreover, when removably secured the casing may be prevented frombeing reconnected to the pump assembly and/or the lumen, oncedisconnection has occurred.

2. Description of the Related Art

The use of endotracheal tubes is well known in the medical profession.In practice, the tube is inserted through the mouth, nose or tracheotomyof the patient into the trachea and is structured, when properlypositioned, to facilitate ventilation from a ventilator or the like.

As conventionally used, the endotracheal tube and/or tracheostomy tubeincludes a coupling structure at the proximal or outer end thereof whichconnects the lumen of the endotracheal and/or tracheostomy tube to thesource of ventilation. The endotracheal and/or tracheostomy tubecommonly includes an inflatable, pressure or retaining cuff which isgenerally disposed in surrounding relation to the distal end of thetube. In use, the cuff is inflated and thereby serves to secure orstabilize the position of the tube as it expands radially outward intoconfronting relation to the walls of the trachea. As a result, theinflated cuff serves to stabilize the position of the endotracheal tubeand also establishes a seal within the trachea. As conventionallystructured, a conduit is associated with the tube and includes aninterior, inflating lumen used to inflate the cuff when the endotrachealtube is properly positioned within the trachea. Dependent on thestructure and use of the endotracheal tube, the inflating line orconduit may be integrally formed on or within the primary wall of thetube itself. As such, the cuff is manually inflated by an appropriateinflation assembly such as, but not limited to, a separate, removablesyringe connected in fluid communication with the inflating lumen.Moreover, the cuff is inflated to a pressure which accomplishes theabove noted seal with the interior of the trachea, as well as effect theaforementioned stabilization of the endotracheal and/or tracheostomytube.

The importance of under inflation, over inflation and/or excessivepressurization of the retaining cuff is well recognized, due to thepotential of resulting injury and/or trauma to the patient. Accordingly,when the pressure within the cuff is too low, the sealing functionthereof cannot be fully achieved resulting in possible leakage ofsaliva, air, etc. into the trachea. However, an over pressurization ofthe cuff may result in reduced blood flow to tracheal tissue, trachealischemic conditions, and cause ulcers, bleeding and tracheal stenosis ortracheomalacia after removal of the tube, which can lead to the need fortracheal repair surgery or even a tracheal transplant. Accordingly, itis important to maintain the inner pressure of the cuff, depended on itsstructure and design, within predetermined ranges in order to affectboth the above noted fluid seal with the trachea as well asstabilization of the endotracheal tube within the trachea.

Known attempts to overcome problems of the type set forth above haveresulted in the provision of various types of pressure gauges or otherpressure monitoring devices connected in fluid communication with theinflating lumen and with the pressure or retaining cuff itself. However,many of these known or conventional attempts to accurately monitor cuffpressure have resulted in less than accurate or satisfactory results.Accordingly, while known monitoring devices may be at least minimallyeffective for their intended function, they have been found to berelatively bulky, cumbersome, costly, and/or less than efficient.Indeed, because of these factors, monitoring devices are often notavailable at the bed side and ET cuff pressure monitoring is ofteninadequately addressed, both initially as well as after the patient isintubated. Moreover, even if a one time, initial pressure identificationis achieved, such is inadequate because the pressure can change overtime, such as when the patient is moved or the endotracheal tube isrepositioned, or when ventilation settings are adjusted. As a result,there is a need in the medical profession for an assembly structured toproperly inflate and continuously monitor the pressure within aretaining or pressure cuff of an endotracheal and/or tracheostomy tube.Further, the inflating and monitoring functions of a proposed monitoringassembly should preferably be carried out by a single unit which may beincorporated within the endotracheal tube assembly or alternatively maybe connected thereto. As such, the monitoring of the pressure within theretaining cuff should be effectively accomplished by a mere visualobservation of the preferred assembly, without requiring repeatedattachment and removal of a pressure monitor and/or inflating device. Inaddition, such a preferred monitoring and inflating assembly should beeasily operable, and in certain preferred embodiments may be structuredto be used as a single use device, which is not integrated into theendotracheal tube, but readily connectable to an inflation lumen of thetube and subsequently detachable there from, but further whereinreconnection of the monitoring assembly is prevented so that reuse ofthe device is prevented to avoid cross-contamination of infection frompatient to patient.

Further, in addition to its applicability within the pressure cuffassociated with an endotracheal tube, it is also recognized that such astructure would be highly beneficial for use within a variety ofdifferent medical devices, including the pressure cuffs, often referredto as balloons or bladders, used in balloon kyphoplasty, balloonsinuplasty, coronary or vascular balloon angioplasty and/or the deliveryof stents, balloon esophageal dilation, and the dilation of stricturesand sphincters, balloon dilatation of the nephrostomytract, and/or SwanGanz catheters, among other medical devices.

SUMMARY OF THE INVENTION

The present invention is directed to an assembly structured to inflateand monitor the pressure within a retaining or pressure cuff, such as ofthe type associated with an artificial airway tube including forexample, but not limited to, an endotracheal and/or a tracheostomy tube.In typical fashion, the retaining or pressure cuff is connected to orassociated with the distal end of the endotracheal tube and is radiallyexpanded, such as by inflation and pressurization. When inflated thecuff serves to retain the associated tube in an intended position withinthe trachea of a patient and form a seal therewith. It is emphasizedthat while the structural and operative features of the assembly of thepresent invention are applicable for use with a retaining/pressure cuff,associated with the aforementioned artificial airway tube(s), it is notintended to be limited to such use. More specifically, the inflation andmonitoring assembly of the present invention can be used to perform theintended and described functions when operatively associated withretaining or pressure cuffs used for a plurality of other purposes.

Accordingly, the assembly of the present invention is structured toefficiently inflate the retaining or pressure cuff so as to orient it ina retaining, sealing position within the trachea. During and subsequentto inflation, the assembly of the present invention is structured tomonitor the existing pressure within the cuff in order to avoid underinflation, over inflation and/or over pressurization thereof. Morespecifically, the assembly of the present invention comprises a casingwhich is connected to the inflating lumen of the endotracheal tube,leading to the retaining cuff, by means of a connection assembly. In atleast one preferred embodiment of the present invention, the connectionassembly is structured to selectively assume a connect orientation or adisconnect orientation. When in the connect orientation the connectionassembly is disposed or oriented to connect to the inflating lumen andestablish and maintain fluid flow between the casing of the assembly andthe interior of the retaining cuff. However, when in the disconnectorientation, the connection assembly is structured to allowdisconnection and removal of the casing from the inflation lumen andfurther structured to prevent reconnection therebetween. Therefore, atleast one preferred embodiment of the present invention comprises asingle-use inflation and monitoring assembly. As a result, once thecasing of the assembly is disconnected from the inflating lumen, it isnot reusable at least to the extent of being reconnected to theinflating lumen. However, structural modifications of the connectionassembly may be included in an additional preferred embodiment, whereinthe inflation and monitoring assembly of the present invention may befixedly and/or permanently connected to the inflation lumen and be usedtherewith as an integrated unit.

Additional structural and operative features associated with theinflation and monitoring assembly of the present invention include theexistence of a pressure chamber on the interior of the casing. Inaddition, a pump assembly preferably, but not exclusively, in the formof a plunger is connected to the casing and movable between andoutwardly extended position and an inwardly directed, compressedposition. Therefore, the pump assembly of the present invention isstructured for selective manipulation to direct fluid flow from anexterior of the casing into the pressure chamber and therefrom through aremainder of the casing and into the inflating lumen attached to thecasing.

A valve assembly is operatively disposed in flow regulating relationbetween the pump assembly and the interior of the pressure chamber. Thevalve assembly includes a first valve structure serving to regulatefluid flow from an exterior of the casing into the interior of the pumpplunger, as the plunger is drawn or forced into the outwardly extendedposition. In contrast, a second valve structure of the valve assembly isstructured to regulate fluid flow from the interior of the plunger intothe interior of the pressure chamber. The inward movement of the plungerinto a compressed position forces air or fluid flow through the pressurechamber and predetermined remaining portions of the casing, through theconnection assembly and into the inflating lumen, through which theforced fluid flow travels to the retaining cuff. The cuff is therebyinflated and pressurized.

One preferred embodiment of the present invention comprises the pumpassembly structured as an integrated and/or permanent part of thecasing. However, it should be noted that a source of air or other fluidused to pressurize or inflate the retaining cuff may be removablyattached to the casing of the monitoring assembly. Such a source ofpressurizing and/or inflating fluid may comprise, but is not limited to,a pump assembly which may or may not have similar operative and/orstructural characteristics as the plunger described herein. Accordingly,a removable pump assembly or other source of inflating fluid can beremovably connected to the casing without departing from the spirit andscope of the present invention.

The assembly of the present invention further includes an indicatorassembly comprising an indicator member movably connected to andvariably positioned within the casing. The indicator assembly isdisposed in direct fluid communication with the interior of the pressurechamber and as a result the position of the indicator member is directlyinfluenced by the existing pressure within the pressure chamber.Moreover, due to the establishment of fluid communication between theinterior of the pressure chamber and the interior of the retaining cuff,the existing pressure in the pressure chamber and the retaining cuffwill be substantially equivalent. In that the existing pressure withinthe pressure chamber is exerted on the indicator member, the indicatormember is “variably positioned” within the casing dependent on themagnitude of the existing pressure within the pressure chamber. Due tothe fact that the existing pressure within the pressure chamber isequivalent to the pressure within the retaining cuff, the variablepositioning of the indicator member will be dependent on and indicativeof the existing pressure within the retaining cuff.

Other operative and structural features include a window disposed on thecasing to facilitate the visual observation of at least a portion of theindicator member. As a result, personnel may easily and efficientlymonitor the pressure within the cuff by visually determining theposition of the indicator member within the casing. Moreover, theportion of the indicator member viewable through the window may includeinformative alpha/numeric indicia, color coding, etc. which provides theobserver with a clear and easily determinable visual indication as to anacceptable or non-acceptable pressure level within the retaining cuff.In addition, in order to further facilitate the visual observation ofthe pressure reading, the window may incorporate a magnifying lens orsimilar structure to make viewing easier. Yet additional embodiments ofthe present invention may include an LED or other appropriate digitalreadout, as well as an audible and/or visual warning in the event of anover inflation condition of the cuff. Also, the inflation and monitoringassembly may be structured to facilitate locating and/or using it whenin a darkened room. Such features may include, but are not limited to,the illumination or “glowing” of the casing and/or other components ofthe assembly when it is used or stored in a darkened area.

Additional structural and operative features of the inflation andmonitoring assembly of the present invention include a pressure reliefvalve assembly including at least one relief valve mounted on the casingin an exteriorly accessible location. Further, the pressure relief valveis disposed in direct fluid communication with the interior of thepressure chamber and in regulating relation to fluid flow vented fromthe pressure chamber to an exterior of the casing. As a result, theselective manipulation of the relief valve will cause a “bleeding” orventing of air or fluid from within the pressure chamber to the exteriorof the casing. As a result the pressure within both the pressure chamberand the retaining cuff may be reduced when it is determined that suchpressure is excessive. In addition, the structuring of the relief valvemay be tapered or otherwise appropriately structured to provide for agradual bleeding or release of pressure from within the pressurechamber.

In order to avoid inadvertent venting or release of the pressure withinthe pressure chamber and retaining cuff, alternately structuredembodiments of the inflating and monitoring assembly of the presentinvention include a restricting assembly or shield assembly. Each ofthese assemblies is selectively positionable on the casing, so as torestrict inadvertent access to the pressure relief valve. In addition,the restricting assembly is structured to removably lock or otherwiserestrictively engage the plunger of the pump assembly in order torestrict its movement and intended operation. In contrast, the shieldassembly is movably mounted on the casing and selectively disposablebetween a closed, valve shielding position and an open, valve activatingposition relative to the relief valve. In addition, the shield assemblyincludes an activating portion deformable or otherwise disposable intoactivating relation and/or engagement with the pressure relief valve,when the shield assembly is in the open, valve activating position.

It should be noted that in the above described embodiments of thepresent invention the pump assembly defining the source of inflatingfluid is generally represented as being permanently or fixedly attachedto the casing. However, in at least one embodiment a source of fluidused to pressurize and inflate the retaining cuff may be removablyattached to the casing of the monitoring assembly. In addition, theremovable source of pressurizing or inflating air or other fluid maycomprise, but is not limited to, a pump assembly which may be similarlyoperative to direct air into and through the casing for purposes ofinflating or pressurizing the retaining cuff. Also, in this additionalpreferred embodiment the casing includes an adaptor assembly structuredto define a single use connection between the casing and the inflatinglumen associated with the retaining cuff.

It is emphasized that while this preferred embodiment is described indetail as establishing a single use connection with an inflating lumenfor a retaining cuff, this embodiment could be used for theestablishment of a single use connection between different medicaldevices. By way of example only, the adaptor assembly could be aneffective in defining a single use connection between different butcooperatively structured medical devices especially, but not limited to,where one of the devices includes a luer type connector, as should beapparent from the following detailed description.

The additional preferred embodiment of the present invention includes anadaptor assembly structured to define a single use connection betweenthe casing and the inflating lumen for the retaining cuff. Moreover, theadaptor assembly includes a housing which may be removably or fixedlyconnected to the casing. In addition, the outlet port connector of thecasing is received within the interior of the adaptor in cooperativerelation with a restrictor. The restrictor is movable within theinterior of the adaptor and in cooperative relation with the outlet portconnector of the casing and in receiving relation to a connectorassociated with the inflating lumen and retaining cuff. Cooperativestructuring between the restrictor and the adaptor serve to facilitatethe movement of the restrictor between a receiving position, anoperative position and an inoperative position. Therefore, therestrictor may be forced to move from the receiving position into theoperative position a sufficient force to accomplish the connection ofthe inflating lumen connector and the outlet port connector. Thedirected force may be exerted on the restrictor by a forced movement orpositioning of the connector of the inflating lumen 15. As set forthabove, once the restrictor is in the operative position, the inflatinglumen connector will or can be disposed in sealing or mating engagementwith the outlet port connector. The aforementioned path of fluid flow isthereby established between the inflating lumen, the interior of thecasing and eventually the retaining cuff.

Additional structural and operative features associated with the adaptorassembly include the provision of an orienting assembly connected to ormounted on the adaptor as well as portions of the restrictor. Morespecifically, the orienting assembly includes a track structure whichpreferably includes a curved and/or angular configuration and mayinclude curved and/or angular ramp portions. In addition, the orientingassembly includes at least one but preferably a plurality of orientingmembers connected to the restrictor and extending at least partiallyoutward there from. The one or more orienting members may be formed of aflexible material having sufficient resiliency to be normally biasedinto engagement with the track structure.

In addition, the adaptor assembly includes the provision of a retainingstructure 430 which may include a plurality of independent and/or spacedapart recesses or other appropriately configured grooves or recesses.The retaining structure may be a part of the track structure and as suchmay be disposed in communicating relation with an appropriatelyconfigured track segment which facilitates the movement of therestrictor form the operative position into the inoperative position.Therefore, upon release of the directed force on the restrictor by theinflating lumen connector, the one or more orienting members travelalong the track segment(s) until they engage or are at least partiallydisposed in a retained relation with the retaining structure.

When so positioned, the orienting members will be substantially fixedwithin or relative to the retaining structure. As a result, when therestrictor is in the inoperative position, it is disposed in obstructingrelation to the inflating lumen connector, thereby preventing orrestricting the positioning of the restrictor by the connector into theoperative position. Moreover, the obstructing position of the restrictorwill restrict the inflating lumen connector from entering the adaptorhousing to a position where the connector can establish theaforementioned path of fluid flow with the outlet port connector of thecasing. Therefore, the adaptor assembly including the provision of theretaining structure and the interaction thereof with the orientingassembly will define a single use connection between the retaining cuffand the inflating lumen. However, it is again emphasized that theadaptor assembly including the provision of the retaining structure andthe interaction thereof with the orienting assembly could be effectivein defining a single use connection between different but cooperativelystructured medical devices especially, but not limited to, where one ofthe devices includes a luer type connector.

Other features associated with the restrictor include it being colorcoded so as to provide a clear indication that the adaptor assembly isin fact a single use device. Such color coding may also be usedindependently of or in combination with appropriate indicia to provide afurther visual indication that the adaptor assembly has been previouslyused and/or is no longer usable.

As set forth above, at least one embodiment of the adaptor assembly isstructured to establish a single use connection of the removal fluidsource with the casing. Accordingly, additional structural and operativefeatures of the adaptor assembly may include a retaining structuredisposed within the housing in engageable relation with the restrictor.The retaining structure is cooperatively structured with the restrictorso as to fixedly maintain the restrictor in the aforementionedinoperative position. Moreover, the inoperative position may be morespecifically defined by the retractor being fixed in an obstructingposition relative to the discharge portion of the removable fluidsource. This obstructing position will prevent connection of thedischarge portion of the fluid source and the outlet port of the casing,thereby preventing the establishment of the aforementioned path of fluidflow. The obstructing position of the restrictor being fixed will alsoprevent the pump assembly from forcing movement of the restrictor intothe aforementioned operative position within the housing.

These and other objects, features and advantages of the presentinvention will become clearer when the drawings as well as the detaileddescription are taken into consideration.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature of the present invention,reference should be had to the following detailed description taken inconnection with the accompanying drawings in which:

FIG. 1A is a front view of one preferred embodiment of the inflating andpressure monitoring assembly of the present invention in an assembled,ready to use, extended orientation associated with an endotracheal tubepressure cuff.

FIG. 1B is a front view of the embodiment of FIG. 1A in a closed orcompressed orientation.

FIG. 1C is a perspective view of another preferred embodiment of theinflating and pressure monitoring assembly of the present invention inan assembled form separated from but connectable to an inflating lumenfor an endotracheal tube.

FIG. 2 is a perspective view in longitudinal section of the embodimentof FIG. 1C represented in a different operative orientation.

FIG. 3 is a longitudinal sectional view of the embodiment of FIGS. 1Cand 2 in an operative orientation.

FIG. 4 is a longitudinal sectional view of the embodiment of FIGS. 1 c,2 and 3 in yet a different stage of operation.

FIGS. 5-7 are detailed longitudinal sectional views of an indicatorassembly of the embodiment of FIGS. 1C and 2-4, in successivelydifferent stages of operation.

FIG. 8 is a detailed longitudinal sectional view in partial cutaway of apressure relief assembly associated with the embodiment of FIGS. 1C and2-7.

FIG. 9 is a detailed longitudinal sectional view of the embodiment ofFIG. 8, wherein the pressure relief assembly is in an open, ventingorientation.

FIG. 10 is a perspective view in partially exploded form of theembodiment of FIGS. 1C and 2-9 wherein a restriction assembly isdisposed in access restricting relation to the pressure relief assemblyof the embodiment of FIGS. 8 and 9.

FIG. 11 is a perspective view in exploded form of the restrictionassembly of the embodiment of FIG. 10 in a non-restricting position.

FIG. 12 is a detailed exploded view in partial cutaway and section of aconnection assembly of the present invention structured to facilitateconnection to an inflating lumen.

FIG. 13 is a detailed sectional view in partial cutaway of theembodiment of FIG. 12 wherein the connection assembly establishes aremovable connection to the remainder of the flushing assembly of thepresent invention.

FIG. 14 is an exploded view in partial cutaway and section, wherein theinflating lumen has been removed from a remainder of the assembly of thepresent invention and wherein the connection assembly is structured todefine a single-use device of the assembly of the present invention.

FIG. 15 is a perspective view in exploded form of the yet anotherembodiment of a connection assembly.

FIG. 16 is a perspective view of the embodiment of FIG. 15 wherein theconnection assembly has established a connection with an inflatinglumen.

FIG. 17 is a perspective view in partial cutaway and exploded form ofthe embodiment of FIGS. 15 and 16, wherein the connection assembly isdisconnected from the inflating lumen, once having been connectedthereto.

FIG. 18 is a longitudinal sectional view of the embodiment of FIG. 1A.

FIG. 19 is a longitudinal sectional view of the embodiment of FIG. 1B.

FIG. 20 is a detail view in partial cutaway of a connection assemblyassociated with an entry port of the embodiment of FIGS. 1A, 1B, andstructurally and operationally similar to that represented in FIGS.12-14.

FIG. 21 is a detail view in partial cutaway of the embodiment of FIG. 20in a different, operative orientation.

FIG. 22 is a detail view in partial cutaway of the embodiment of FIGS.20 and 21 in a closed, obstructing orientation.

FIG. 23 is a longitudinal sectional view of another preferred embodimentof an inflating and pressure monitoring assembly of the presentinvention.

FIG. 24 is an exterior view of the embodiment of FIG. 23.

FIG. 25 is an interior perspective view in partial cutaway of an adaptorassembly included in the embodiment of FIGS. 23 and 24, wherein theadaptor assembly is in a “receiving position”.

FIG. 26 is an interior perspective view in partial cutaway of theadaptor assembly of FIG. 25 in an “operative position”.

FIG. 27 is an interior perspective view in partial cutaway of theembodiments of FIGS. 25 and 26 in an inoperative position.

FIG. 28 is a longitudinal sectional view of the embodiments of FIGS.25-27 in the receiving position as represented in FIG. 25.

FIG. 29 is a longitudinal sectional view of the embodiments of FIGS.25-28 in the operative position as represented in FIG. 26.

FIG. 30 is a longitudinal sectional view of the embodiments of FIGS.25-29 in the inoperative position as represented in FIG. 27.

FIG. 31 is a longitudinal sectional view of yet another preferredembodiment of an inflating and pressure monitoring assembly of thepresent invention, similar to the embodiment of FIG. 23.

Like reference numerals refer to like parts throughout the several viewsof the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As shown in the accompanying drawings, the present invention is directedto an inflation and pressure monitoring assembly generally indicated as10. The assembly 10 structured to inflate and monitor the pressurewithin a retaining cuff or pressure cuff of a medical device, includingin the preferred embodiment the type associated with an endotrachealtube. It is understood, however, that the pressure cuff, often referredto as a balloon in some devices, could be included as part of medicaldevices used in balloon kyphoplasty, balloon sinuplasty, coronary orvascular balloon angioplasty and/or the delivery of stents, balloonesophageal dilation, and the dilation of strictures and sphincters,balloon dilatation of the nephrostomytract, and/or Swan Ganz catheters,among other medical devices.

More specifically, the assembly 10 includes a generally elongated casing12 having a distal end generally indicated as 14 structured to beinterconnected to an inflation lumen 15, which will be described ingreater detail hereinafter, by means of a connection assembly 17. Theconnection assembly 17 is accessible through a receiving port 14′associated with the distal end 14 of the casing 12, and will bedescribed hereinafter with primary reference to FIGS. 12 through 17. Assuch, the assembly 10 is intended to be interconnected in fluidcommunication with the inflation lumen 15 and in turn is therebydisposed in direct fluid communication with the interior of theretaining or pressure cuff associated with the inner or distal end ofthe endotracheal tube and not shown for purposes of clarity.

With primary reference to FIGS. 1C and 2-4, the casing 12 includes an atleast partially hollow interior more specifically defined by a pressurechamber 16. A pump assembly generally indicated as 18 is preferably inthe form of a plunger 20 having an outer end 20′ and an elongated stemor barrel portion. The pump assembly 18 and specifically including theplunger 20 includes a hollow interior 24 extending along substantiallythe entire length or at least a majority of the length of the plunger20. The plunger 20 is movably connected to the casing 12 and isselectively disposed between an inwardly directed compressed position asrepresented in FIG. 2 and an outwardly directed, extended position asrepresented in FIGS. 1C, 3 and 4. Moreover, manipulation of the plunger20 of the pump assembly 18 will force fluid flow from an exterior of thecasing 12 into the pressure chamber 16 and through predeterminedportions of the casing 12 to the inflation lumen 15, thereby serving toinflate and pressurize the retainer cuff.

In order to regulate fluid flow to the retainer cuff and maintain apredetermined, acceptable pressure level therein, a valve assembly 28 isassociated with the pump 18 and specifically the plunger 20. The valveassembly 28 is disposed in fluid regulating, interconnecting relationbetween the pressure chamber 16 and the interior 24 of the plunger 20.As such, the valve assembly 28 is disposed and structured to regulatefluid flow from an exterior of the casing 12 into the interior 24 of theplunger 20 and therefrom into the pressure chamber 16. Morespecifically, the valve assembly 28 includes a first valve structure 30and a second valve structure 32 both structured in the form of one-wayvalves. In at least one preferred embodiment of the present invention,the first one-way valve structure 30 and the second one-way valvestructure 32 are integrally or fixedly attached and cooperativelyoperational so as to regulate fluid flow from the exterior of the casing12, into the pressure chamber 16 and therefrom into the inflation lumen15 and into the retaining cuff associated with the endotracheal tube.

In operation, when in the compressed position of FIG. 2, the valveassembly 28 is effectively inoperable since there is no forced orintended fluid flow through the casing 12. However, a withdrawal oroutward positioning of the plunger 20 into the extended position, asrepresented in FIGS. 1C, 3 and 4, will result in the first one-way valvestructure 30 opening thereby allowing air to be drawn into the interior24 of the plunger 20 about the periphery of the first one-way valvestructure 30, such as at 33. During the filling of the interior 24 ofthe plunger 20, the second one-way valve structure 32 will remainclosed, thereby preventing fluid flow from the interior of the pressurechamber 16 into the interior 24 of the plunger 20. However, once theplunger 20 is forced inwardly into the casing 12 and toward and into thecompressed position of FIG. 2, the inwardly directed force, indicated bydirectional arrow 35 in FIG. 3, will cause a closing of the firstone-way valve structure 30 and a concurrent opening of the secondone-way valve structure 32. As a result, the air or other fluidcollected within the interior 24 of the plunger 20 will be forcedthrough the second one-way valve structure 32 into the pressure chamber16. Accordingly, it should be apparent that the first and second one-wayvalve structures 30 and 32 will automatically and alternatively bedisposed in an opened/closed position as the plunger 20 is withdrawn outinto its extended position and subsequently forced inwardly into itscompressed position as represented in FIGS. 2-4.

Therefore, the air or other fluid forced into the pressure chamber 16will pass into a delivery channel 40 having an entrance 42 communicatingdirectly with the interior of the pressure chamber 16. An exit ordelivery end of the channel 40 is designated as 44, wherein an end mostchannel segment 44′ will deliver a forced fluid flow through theconnecting assembly 17 directly to the connecting collar 80 of the hub82, of the inflating lumen 15. The end channel segment 44′ is passesthrough the connecting assembly 17 and is disposed in fluidcommunication with the connecting collar 80 through the receiving port14′ associated with the distal end 14 of the casing 12. As set forthabove, the distal end 14 may be removably connected to the inflatinglumen 15, as primarily represented in FIGS. 12-14, by an interconnectionbetween the connecting assembly 17 and the connecting collar 80 and hub82, as will be described in greater detail hereinafter with primaryreference to FIGS. 12-15.

Therefore, it should be apparent that a forced fluid flow from theinterior of the plunger 20 into the pressure chamber 16 will serve todeliver a predetermined quantity of air or other inflating fluid throughthe pressure chamber 16 and into and along the length of the channel 40.Such fluid flow will continue to pass through the exit end 44 andchannel segment 44′ of the channel 40 and exit from the casing 12through the receiving port 14′. Therefore the pressure chamber 16 andthe interior of the retaining or pressure cuff will normally bemaintained in fluid communication with one another. As a result the“existing pressure” within the pressure chamber 16 will be the same asthe pressure within the inflated retainer cuff, as long as the casing 12is operatively connected to the inflating lumen 15.

While at least one preferred embodiment of the present inventioncomprises the pump assembly 18 structured as an integrated and/orpermanent part of the casing 12, it is noted that the a removable pumpassembly, having similar operative and structural characteristics suchas, but not limited to, a removably connected syringe type assembly, canbe removably connected to the casing 12 without departing from thespirit and scope of the present invention.

Another feature of at least one preferred embodiment of the presentinvention is the provision of an indicator assembly generally indicatedas 50 represented in different stages of operation in FIGS. 5-7,dependent on the magnitude of the “existing pressure” within thepressure chamber 16 and accordingly, within the retaining cuff. Morespecifically, the indicator assembly 50 includes an indicator member 52movably disposed on and more specifically within the casing 12 in directfluid communication with the pressure chamber 16. Accordingly, anyexisting pressure within the pressure chamber 16 will be cause a forceto be exerted on the indicator assembly 50 and more specifically on theindicator member 52. As also represented, the movement of the indicatormember 52 is at least partially the result of it being biasingly mountedor disposed within the interior of the casing 12. Such a biased mountingor connection of the indicator member 52 is accomplished through theprovision of a biasing member 54 preferably, but not necessarily,including at least one spring. As such, the biasing member 54 typicallybiases the indicator member 52 in a direction towards the pressurechamber 16 and against or in confronting relation with the bladder 56defining an interconnecting member, which is associated with the withthe indicator assembly 50, as explained in greater detail hereinafter.Accordingly, the biasing member 54 biases the indicator member 52against the existing force present within the pressure chamber 16.

Therefore, as a result of the forces concurrently exerted on theindicator member 52 by the biasing member 54 and the existing pressurewithin the pressure chamber 16, the indicator member 52 is “variablypositioned” within the interior of the casing. The biasing force exertedon the indicator member 52 by the biasing member 54 and may bepredetermined and as such relatively constant or at least predictable.Accordingly, the movement of the indicator member 52 and its variableposition within the casing 12 is directly dependent on the magnitude ofthe existing pressure within the pressure chamber 16 and the resultingvariable force exerted on the indicator member 52. Additional structuraland operative features of the indicator assembly 50 include theaforementioned interconnecting member in the form of the bladder 56,formed of a flexible material. The bladder 56 includes an open end 56′disposed and dimensioned to establish direct fluid communication withthe interior of the pressure chamber 16. The opposite end or otherappropriate portion as at 56″ is connected to or is otherwise disposedin confronting, driving relation to a corresponding portion of theindicator member 52. Any existing pressure within the pressure chamber16 will result in a proportional force being exerted on the flexiblematerial bladder 56 and transferred to the indicator member 52 andagainst the biasing force exerted on the indicator member 52 by thebiasing member 54. Therefore, the existing pressure within the pressurechamber 16 will exert a variable force on the bladder 56 and thereby onthe indicator member 52 and against the biasing member 54, depending onthe magnitude of this existing force.

With primary reference to FIGS. 5-7 and a comparison of the position ofthe indicator member 52 in these Figures, it is clearly demonstratedthat the variable position of the indicator member 52 will be dependenton the force exerted on the bladder 56 and indicator member 52 based onthe magnitude of the existing pressure within the pressure chamber 16and the counteracting force exerted on the indicator member 52 by thebiasing member 54.

More specifically, FIG. 5 represents one operative position of theindicator member 52, wherein a first, relatively smaller amount of forceis exerted on the indicator member 52 due to a smaller magnitude ofexisting pressure within the pressure chamber 16. However thisrelatively smaller force is still adequate to at least partiallyovercome the biasing force exerted on the indicator member 52 by thebiasing member 54. In contrast, the position of the indicator member 52indicates that the magnitude of the existing pressure within thepressure chamber 16 has significantly increased and is proportionatelygreater than the biasing force exerted on the indicator member 52 by thebiasing member 54 in that the indicator member 52 is forced more closelyto the proximal end 14 and against the biasing member 54. Moreover, FIG.7 represents an even greater increase in the force being exerted on thebladder 56 and indicator member 52, due to a significantly greaterincrease in the magnitude of the existing pressure within the pressurechamber 16. As a result, the position of the indicator 52 has againvaried as it is forced even more closely to the proximal end 14 of thecasing 12.

Accordingly, it is again emphasized that the existing pressure withinthe pressure chamber 16 will be substantially equivalent to the existingpressure within the retaining cuff associated with the endotracheal tubewhen it is inflated. This is due to the open line of fluid communicationbetween the pressure chamber 16 and the interior of the retainer cuffonce inflated and when the pump assembly 18 specifically including theplunger 20 is in its compressed position as represented in FIG. 2.Therefore, the variable position of the indicator member 52 within thecasing 12 is indicative of the magnitude of pressure within theretaining cuff as well as the pressure chamber 16.

Additional features associated with the indicator assembly 50 preferablyinclude the provision of indicating indicia 53 present on the exteriorsurface 52′ of the indicator member 52. Further, the casing 12 includesa window or like structure 58 which facilitates a visual observation ofthe exterior surface 52′ of the indicator member 52 as well as theindicating indicia disposed thereon. Such indicating indicia 53 may bein the form of a color coded segment or segments on the exterior surface52′ and/or any type of other appropriate markings which are disposed andstructured to facilitate a clear visual indication of an adequate orproper pressure within the pressure chamber 16 and accordingly withinthe retaining cuff. By way of example only, a color coded portion mayexist on the exterior surface 52′ which will provide an individual,having visual access to the window 58, with a clear indication that atleast the minimum or adequate amount of pressure exists within theretainer cuff. Such color coding may include a “red” surface areasegment which will quickly inform an observer that the retainer cuff maybe over inflated or include excess pressure on the interior thereof.

In addition, a magnifying lens or other magnifying structure may beincluded in or as part of the window 58, in order to further facilitatethe visual observation of the indicating indicia 53 on the surface 52′.Yet additional embodiments of the present invention may include an LEDor other appropriate digital readout, as well as an audible and/orvisual warning, associated with the exterior of the casing 12, such asin the vicinity of the window 58, in the event of an over inflationcondition of the cuff.

In order to properly inflate, monitor and if necessary regulate theexisting pressure within the pressure chamber 16 and accordingly withinthe retainer cuff, at least one preferred embodiment of the presentinvention includes a pressure relief assembly generally indicated as 60,as represented in FIGS. 8 and 9. The pressure relief assembly 60includes a pressure relief valve 62, disposed in fluid sealing relationto the interior surfaces of the vent port or opening 63, wherein thevalve 62 is accessible from the exterior of the casing 12 asrepresented. Further, the pressure relief valve 62 may be normallymaintained in a closed position, as clearly represented in FIG. 8, dueto the provision of a biasing member 64 in the form of one or morebiasing springs. The biasing member 64 is disposed and structured tomaintain the pressure relief valve 62 in a closed orientation unless anexternal, depressing pressure or force is applied thereto. As a result,in situations where the retainer cuff becomes over inflated or overlypressurized, the relief valve 62 may be depressed or otherwisemanipulated to open the relief valve 62 thereby venting the existingpressure from within the pressure chamber 16. This in turn will cause achange in the force exerted on the indicator member 52 and result in aposition change of the indicator member 52 in a direction toward thepressure chamber 16. Such variable positioning of the indicator member52 will be observable through the window 58 in the casing 12 asrepresented throughout the accompanying Figures relating to thisembodiment. In addition, the structuring of the relief valve 62 mayinclude a substantially tapered configuration, as at 62′ in FIGS. 8 and9, or other appropriate structural configuration to accomplish sealingengagement with the interior surfaces of the vent port or opening 63.This preferably tapered structure provides for a gradual bleeding orrelease of pressure from within the pressure chamber.

The provision of a pressure relief assembly 60 may be necessary and/ordesirable to maintain an adequate control of the existing pressurewithin the pressure chamber 16. However, care must be taken to avoid orprevent any inadvertent venting of the existing pressure within thepressure chamber 16. Accordingly, at least one preferred embodiment ofthe present invention includes a restricting assembly generallyindicated as 70. The restricting assembly 70 includes a fingermanipulated slide structure 72 movable along the exterior of the casing12, such as along the one or more rails 74.

With primary reference to FIGS. 2, 3 and 11, the finger manipulatedslide member 72 is disposed along an exterior portion of the casing 12in spaced relation from the pressure relief assembly 60, therebyallowing clear access to the pressure relief valve 62. However, incontrast, FIGS. 1C, 4 and 10 represent the position of the restrictingslide member 72 in the position which restricts access to the pressurerelief assembly 60 and in particular the pressure relief valve 62. As aresult, the pressure relief valve 62 cannot be inadvertently orpurposefully depressed thereby restricting an inadvertent venting of thepressure chamber 16 while the slide member 72 is in the restrictingposition.

As also noted in FIG. 4, when the slide member 72 is in the restrictingposition as indicated, a portion thereof as at 72′ engages a lock orblocking structure 73 which may be selectively disposed into blocking orinterruptive engagement with an end portion of the plunger 20, therebypreventing it from being forced inwardly into the aforementionedcompressed position as represented in FIG. 2. As a result, therestricting assembly 70, specifically including the restricting slidemember 72 is disposable on the casing 12 in movement restrictingrelation to the pump assembly 18 and in particular, the plunger 20. Asalso indicated in the embodiment of FIG. 4, the structure, dimension andconfiguration of the restricting member 72 may be such as toconcurrently restrict movement of the plunger 20 as well as access tothe pressure relief valve 62 of the pressure relief assembly 60.

With primary reference to FIGS. 12-14, yet another preferred embodimentof the inflating and monitoring assembly 10 of the present inventioncomprises a connecting assembly 17. The structural and operativefeatures of the connecting assembly 17 are such as to allow for only asingle-use of the casing 12 and the various operative componentsassociated therewith. More specifically, the connecting assembly 17 isdirectly associated with the distal end 14 of the casing 12 and isaccessible through the receiving or connecting port 14′. As such, thereceiving or connecting port 14′ is dimensioned and configured toreceive a connecting collar or like structure 80 associated with the hub82 of the inflating lumen 15. The connecting collar 80 may be, but isnot limited to, a, luer type connector structured for connection to acooperatively disposed and structured male luer type connector 43. Theconnecting collar 80 is dimensioned and configured to pass through theconnecting port 14′, as represented in FIG. 13. Once so positioned, aretaining member 90 associated with the connecting assembly 17 is forcedback into non-retaining relation with a gripping structure 92, as alsorepresented in FIG. 13.

Although not specifically represented, the gripping structure 92 isassociated with an appropriate biasing structure, which is disposed tobias the gripping structure 92 in a direction towards the connectingport 14′. Further, the retaining member 90, while being initiallydisposed adjacent to and/or extending outwardly from the port 14′, ismovable on or relative to the gripping structure 92 in direction awayfrom the port 14, as the collar 80 passes through the port 14′ andengages the retaining member 90. Accordingly, a comparison of FIGS. 12and 13, clearly indicate that the retaining member 90 may be initiallydisposed, along with the other components of the connecting assembly 17,into a “connect position”. However, upon entry of the collar 80 throughthe receiving port 14′, the retaining member 90 is forced back away fromthe gripping structure 92, against the force exerted thereon by theaforementioned biasing structure. Advancement of the collar 80 throughthe port 14′ and on to the male luer type fitting or like connector 43accomplishes a frictional or other confronting engagement between theinterior surface 80′ of the hub 80, and an exterior preferably taperedsurface 43′ of the male connecting member 43. As a result, a fluid tightseal and connection is established between the interior surface 80′ ofthe hub 80 and the exterior surface 43′ of the nozzle or male luer typefitting.

With primary reference to FIGS. 13 and 14, a single use structuring ofthe connecting assembly 17 is demonstrated. More specifically, as theretaining member 90 is forced inwardly into the interior of theconnecting assembly housing 17′ it is effectively removed from aretaining relation to the outermost end 92′ of the gripping member 92.Accordingly, as the casing 12 is disconnected from the inflating lumen15, the collar 80 will be withdrawn from the interior of the connectingassembly housing 17′, while the retaining member 90 will remain in theposition represented in FIG. 14. However, due to the biasing forceexerted on the gripping structure 92, as set forth above, the end 92′will be forced out of the connecting port 14′ as indicated. As a result,the end 92′ will assume a blocking or disconnect orientation due in partto a latching structure 92″ formed on the outer surface of the end 92′.This latching structure 92″ will overlap and effectively be latched ontothe outer periphery of the connecting aperture 14′ and thereby preventthe end 92 from passing back through the connecting aperture 14′ intothe interior of the connection assembly housing 17′.

As a result, it will be impossible or extremely difficult for the casing12 to be reconnected to the hub 82 or collar 80 of the inflating lumen15 once it has been disconnected there from, due at least in part to thefact that the collar 80 will not be able to be inserted back through thereceiving or connecting port 14′ into engagement with the male connector43. It should be apparent therefore, that in the embodiment of FIGS.12-14, the casing 12 can be easily and quickly removed from itsoperative connection to the inflating lumen 15 but once removed ordisconnected cannot then be reconnected, as set forth above.

In addition to the above, at least one embodiment of the connectionassembly 17 comprises the retaining member 90 and the gripping member 92being of different, contrasting colors thereby clearly indicatingwhether the assembly 10 and the casing 12 is in the connect orientationand ready for us or in the disconnect orientation and has already beenused. More specifically, as represented in FIG. 12 the casing 12 and theconnection assembly 17 are in the connect orientation and have not beenused in that the connection assembly 17 has not yet been connected tothe collar 80 of the inflating lumen 15. As a result, the retainingmember 90 is clearly visible through the connecting aperture 14′. Incontrast, FIG. 14 represents the casing 12 and connection assembly 17being in the disconnect orientation, wherein the collar 80 andconnection assembly 17 having been disconnected from one another.Moreover, after use the gripping member 92 is clearly visible throughthe connecting aperture 14′ and the retaining member 90 can no longer beseen. Accordingly, the production of the retaining member 92 and thegripping member in contrasting colors such as, but not limited to, greenfor the retaining member 90 and red for the gripping member 92, willprovide a clear and readily observable indication as to whether or notthe casing 12 has or has not been used.

As set forth above, the embodiment represented in FIGS. 12-14 isstructured to accomplish a “single-use” inflation and monitoringassembly 10. However, structural modifications representing yet anotherembodiment of the present invention include the casing 12 beingintegrally, fixedly and/or at least partially permanently connected tothe inflation lumen 15 such as by the interconnecting hub 82 and collar80. In such an additional preferred embodiment, the structural andoperative features of the connecting assembly 17 may be cooperativelymodified along with the collar 80 and the hub 82 to accomplish theintegration of the casing 12, collar 80 and hub 82 as a single unit.

With primary reference to FIGS. 15-17, yet another embodiment of theconnection assembly is generally indicated as 117. While not directlydisclosed, the connection assembly 117 is dimensioned and configured forinsertion within the connection shell or housing 17′ by being insertedthrough the connecting or receiving port 14′. Moreover, the connectionassembly 117 includes a connection housing 118 having an open proximalend as at 120 and an open distal end as 122. When in a connectorientation, as represented in FIG. 15, member 124 is initiallypositioned in track segment 126. Upon engagement with the connectingcollar 80 of the inflating lumen 15, the indicator member 24 willautomatically be forced into the intermediate orientation represented inFIG. 16. As such, the indicator member 24 will be forced out of thetrack segment 26 and be disposed as at a junction area 128 between thetwo track segments 126 and 129. Interaction between the connectingcollar 80 and interior member 130 will cause the automatic dispositionof the member 124 into the orientation or position represented in FIG.16. Accordingly, the connection assembly 117 is designed to facilitateinterconnection between the connecting collar 80 and end 120 of theconnection housing 118 by being disposed in confronting engagementtherewith or passing into the interior of the open end 120 into engagingrelation with the interior member 130.

Structural features of the connection assembly 117 further provide forthe removal or disconnection of the hub 180 from the connection assembly117 as represented in FIG. 17. Accordingly, once a disconnection occursbetween the connecting collar 80 the member 130, due to a biasedconnection and/or structure, will be forced outwardly through theopposite open end 122 concurrent to the movement or passage of themember 124 passing along the track segment 129 to an inner most endthereof, as also represented in FIG. 17. Therefore, the connectionassembly 117, as represented in FIG. 17, at least partially defines adisconnect orientation or position of the connection assembly 117 inthat the protrusion of the member 130 outwardly from the interior of theconnection housing 118 will prevent reconnection of the connecting hubwith or into interior of the housing 118. As a result, the connectionassembly 117 is thereby structured to facilitate the casing 12 beingstructured as a “single-use” device due to the fact that the connectionassembly 117 will not allow reconnection with the connecting collar 80of the inflating lumen 15.

As represented in FIGS. 1A, 1B and 18-22, the present inventioncomprises yet another preferred embodiment of the inflation and pressuremonitoring assembly and is generally indicated as 110. The assembly 110is structurally and functionally similar to the inflation and monitoringassembly 10, as represented at least in FIGS. 1C-14, described above.However, the assembly 110 includes additional structure and operativefeatures which are distinguishable from the assembly 10, wherein suchdistinguishing features are described in greater detail hereinafter.

More specifically, the structure of FIGS. 1A, 1B and 18-22 comprises a“single-use” inflation and monitoring assembly 110. However, structuralmodifications which may be associated with the assembly 110 mayfacilitate the casing 112 being integrally, fixedly and/or at leastpartially permanently connected to the inflation lumen 15, such as bythe interconnecting hub 82 and collar 80. Moreover, the elongated casing112 has a distal end 114 which includes a connection assembly 217structured to removably interconnect the casing 112 to an inflationlumen 15 (see FIG. 2) as well as the hub 82 and collar 80 which is alsodescribed above. Moreover, the connection assembly 217 is accessiblethrough the receiving port 114′ and will be described in greater detailhereinafter with specific reference to FIGS. 20-22.

As best represented in FIGS. 18 and 19, the casing 112 includes apressure chamber comprising a multi-chamber construction including afirst chamber 300 and a second chamber 302. In addition, the casing 112comprises an integrated pump assembly preferably in the form of aplunger 120 also integrated into and at least partially defining thestructure of the casing 112. The integration of the pump assembly andplunger 120 into the casing 112, as a part thereof, overcomes thedisadvantages of requiring a separate, pump assembly, plunger, etc.removably associated with the casing. The plunger 120 includes a handmanipulated end portion or knob 120′ and a hollow interior 24 which isdirectly associated with a valve assembly 28. The plunger 120 isdisposable between an open, outwardly extended, ready to use orientationor position, as demonstrated in FIGS. 1A and 18 and a compressedorientation as represented in FIGS. 1B and 19. As explained in greaterdetail hereinafter, the plunger 120 may be retained in such a closed orcompressed position. The plunger 120 is normally biased by biasingstructure 121 into the orientation of FIGS. 1A and 18. The operation orreciprocal movement of the plunger 120 serves to pressurize both thefirst chamber 300 and the second chamber 302 through appropriatechanneling 305, 307.

Although not specifically represented, the fluid connection between thefirst and second chambers 300 and 302 respectively is disposed withinthe casing 112 and establishes fluid communication there between. Uponreciprocal movement of the plunger 120 between the extended position ofFIGS. 1A and 18 and the inwardly compressed position of FIGS. 1B and 19,fluid flow will be forced from the first chamber 300 sequentially intothe second chamber 302 and eventually out to the retaining cuff by meansof the lumen 15, hub 82 and connecting collar 80 as represented in FIG.2. The sequential passage of pressurized fluid, upon manipulation of theplunger 120 will establish the aforementioned sequential pressurizationor fluid flow from the first chamber 300 to the second chamber 302through the connecting channels 305 and 307. In addition, the connectoror luer fitting 143 includes an interior fluid channel 144 which isconnected in direct fluid communication with the interior of the secondchamber 302. Accordingly, the sequential pressurization of the secondchamber 302 through the manipulation of the plunger 120 will force fluidflow from the second chamber 302 through the lumen or flow channel 144of the connecting luer type fitting or conduit 143. Therefore it isclearly established that the fluid channel 144 is disposed in directfluid communication with the second chamber 302.

With further reference to FIGS. 1A, 1B, 18, 19, this additionalpreferred embodiment includes an indicator assembly generally indicatedas 310 and including a reaction member 312. The reaction member 312includes a collapsible or flexible construction which facilitates itbeing disposed between the outwardly extended position as represented inFIGS. 18 and 19 and an inwardly, at least partially compressedorientation (not shown for purposes of clarity). A biasing structure 314is disposed within the hollow interior 316 of the reaction member 312.The biasing structure 314 is disposed to biasingly engage and therebybiasingly mount or position the reaction member 312 into the extendedposition as represented in FIGS. 18 and 19. As such the reaction member312 is biased against any pressure build up within the second chamber302. Therefore, an increase or maintenance in the pressure within thesecond chamber to a predetermined level will variably position thereaction member into a compressed orientation dependent on the degree ofpressure.

Moreover, the reaction member 312 is connected to or considered a partof the indicator 312′ which is visually observable through a window 158formed on the exterior of the casing 112. Accordingly, viewing of theexterior of the casing in the area disclosed in FIGS. 1A and 1B allowsan observer to determine the position of a marker 53 as it moves withinthe window 158 relative to informative indicia 315 and 317. Theindicated indicia are indicative of the existing pressure within atleast the second chamber 302 and the retaining cuff by virtue of theestablishment of fluid pressure therebetween through the fluid channel144. Accordingly, the reaction member 312 will move against the biasingforce exerted thereon by the biasing structure 314 as the pressurewithin the second chamber 302 builds. Again the pressure within thesecond chamber 302 is substantially equivalent to that maintained withinthe retaining cuff. Accordingly, the variable movement of the reactionmember 312 into its various compressed orientations will result inmovement of the marker 53 which is connected to the reaction member312/indicator member 312′. The variable movement of the marker 53 willbe viewable through the window 158, as set forth above.

Other structural features associated with the indicator assembly 110include the hollow interior 316 as well as the reaction member 312itself being physically isolated from the first chamber 300, such as bypartition structure 333 in order to better provide an accurate responseby substantially equivocating the pressure within the second chamber 302to the pressure within the retaining cuff. However, the indictorassembly 310 further includes a vent structure 320 disposed in fluidcommunication between the interior 316 of the reaction member 312 and anexterior of the casing 112, as represented at 320′. Vent structure 320is disposed and structured to regulate fluid flow into and out of thehollow interior 316 as the reaction member 312 moves with and againstthe biasing force of the biasing structure 314. More specifically, abuild up of the pressure within the second chamber 302 will force thereaction member 312 into a compressed orientation thereby forcing fluidfrom within the hollow interior 316 out through the vent 320. Movementof the reaction member 312 in the opposite, outwardly extended position,upon absence of significant pressure within the chamber 302 will allowair or fluid to be drawn into the interior 316 through the ventstructure 320.

With further reference to the embodiments of FIGS. 1A, 1B, 18 and 19,the inflation and monitoring assembly 110 further includes a shieldassembly generally indicated as 330. The shield assembly 330 is movableon the exterior of the casing 112 by manipulation of the fingers of theuser of the casing 112. More specifically, as represented in FIGS. 1Aand 18, the shield assembly 330 is disposed in closed orientation and assuch is disposed in shielding relation to the relief valve assembly 160including the valve stem 162. The shielding assembly 130 once in theclosed position of FIGS. 1A and 18 restricts access to the valve stem162 such that the relief valve 160 can not be depressed against thebiasing force exerted by the biasing member 164 and opened. The reliefvalve 160 therefore remains closed so as to maintain the pressure withinthe first chamber 300. However, movement of the shield assembly 330 inaccord with directional arrow 331 serves to dispose the shield assembly330 in at least a partially open orientation. As such, the shieldassembly 330 includes an activating portion 332 formed of an at leastpartially flexible or otherwise deformable material. Therefore, adownward pressure, exerted by the fingers of the user, on the activatingportion 332 will serve to engage and force open the valve stem 162thereby allowing at least partial release of the pressure from withinthe pressure through the first chamber 300. Accordingly, the activatingportion 332 of the shield assembly 330 is at least partially deformable,as schematically indicated at 332′ by exerting a downwardly or inwardlydirected pressure as also schematically indicated at 332′.

Yet additional structural and operative features included in theadditional preferred embodiment of FIGS. 1A, 1B, 18 and 19 include theprovision of a retaining assembly 350 disposed at least partially on andaccessible from an exterior of the casing 112. More specifically, theretaining assembly 350 is disposed and structured to fixedly orremovably retain the plunger 118, including the plunger head 118′, intothe closed position represented in FIGS. 1B and 19. The retainingassembly 315 includes at least one but preferably two oppositelydisposed retaining members 352. Moreover, each of the retaining members352 are movably, flexibly or pivotally connected to the casing, as at354, such that they may be forced inwardly in accord with directionalarrows 355, by the fingers of the hand of the user. However, a naturalorientation of the retaining members 352 is an outwardly disposedposition, as represented in FIG. 18, due at least in part to an inherentor structural biasing force being exerted thereon.

In addition, each of the retaining members 352 include a free endportion 352′ which are cooperatively structured with correspondinglydisposed parts of the plunger head 120′, as at 120″. When the one ormore retaining members 352 are in the orientation represented in FIG.19, an inwardly forced positioning of the plunger head 120′ will cause alocking engagement between the ends 352′ and the portions 120″ of theplunger head 120′. Release of the one or more retaining members 352 andthe corresponding ends associated therewith from locking or retainingengagement from the plunger head 120′ can be accomplished by an inwardforce on the one or more retaining members 352, as schematicallyrepresented at 355.

With primary reference to FIGS. 20-22, the additional preferredembodiment of the inflation and monitoring assembly 110 includes aconnection assembly 217. The connection assembly 217 is structurally andoperationally similar and in some instances identical to the connectionassembly 17 as represented in FIGS. 12-14, and described above. Morespecifically, the connection assembly 217 includes a retaining member 90and a gripping structure 92 disposed within the receiving port 114′associated with the corresponding end 114 of the casing 112. Moreover,the retaining member 190 is movable relative to the gripping portion 92as the collar 80, associated with the lumen 15 (see FIGS. 12-14), isdisposed into and through the entry port 114′. Such movement will causean inward movement of the retainer member 90 relative to the grippingportion 92.

As also set forth above, the connecting portion 217 is intended to be ofa single use construction. Upon the inward forced movement of theretaining member 90 it is removed from its retaining relation to theoutermost end 92′ of the gripping structure 92. The inward forced travelof the retaining member 90 is caused by the insertion thereof of thecollar 80, as described in detail with reference to FIG. 13. However,upon the removal of the collar 80, the end 92′ of the gripping structurewill be forced out through the port 114′ as clearly demonstrated in FIG.22. As a result, the end 92′ will assume a blocking and disconnectorientation. As a result, it will be extremely difficult, if notimpossible, for the casing 112 to be reconnected to a hub 82 or collar80 of an inflating lumen 15 once it has been disconnected.

As described in detail with the above noted embodiments, a source ofinflating air or fluid used to inflate and pressurize the retaining cuffmay take a variety of forms such as, but not limited to a syringe orlike pump assembly. It is also indicated the pump assembly or source ofinflating fluid may or may not be fixedly attached to the remainder ofthe inflating and monitoring assembly. Accordingly, the presentinvention includes an additional preferred embodiment, represented inFIGS. 23-31, wherein the pump assembly, syringe or other source ofinflating fluid is not necessarily permanently connected to theremainder of the inflating an monitoring assembly 360.

As such, the inflating and monitoring assembly 360 includes a casing 362having at least one pressure chamber 364. The pressure chamber 362 isdisposed in fluid communication with a pump assembly or source ofinflating fluid, which may be removably or fixedly connected to an inletportion 366 of the casing 362. More specifically in the embodiment ofFIG. 23, the inlet portion 366 includes a connector 368 directlyassociated with a valve assembly 370. The valve assembly 370 is normallybiased into a closed or sealing position relative to a flow path 369disposed, configured and structured to be connected to the dischargeportion of the syringe, pump assembly, or other source of inflatingfluid (not shown). As further represented, the valve assembly 370 ismaintained in a sealed, closed orientation due to the cooperativepositioning and structuring of the seal member 371 and biasing member372.

Somewhat similar to the operative and structural features of at leastsome of the preferred embodiments of FIGS. 1-22, the pressure chamber364 is disposed in fluid communication with the inflating and/orpressurizing air forced into the casing 362 by operation of the pumpassembly, syringe, etc. A connecting channel or passage 440 is in directcommunication with the inlet portion 366 as well as channel or passagesegments 440′. As indicated, channels or passages 444 continue passageof the inflating or pressurizing fluid from the valve assembly 369 intothe interior of the pressure chamber 364. The inflating air, oncepassing into the pressure chamber 364, interacts with the diaphragm 390.The diaphragm 390 is cooperatively disposed and structured with abiasing member 373 and therefore is operatively structured similar tothe equivalent or corresponding structures of the embodiments of FIGS.1-22.

An additional structural modification is represented in FIG. 31 andincludes the use of a collapsible bellows structure 390′ as an operativesubstitution for the diaphragm 390, as described with reference to FIG.23. The inflating air, once passing into the pressure chamber 364,interacts with the bellows 390′and is therefore operative in the samemanner as the diaphragm 390. In addition, the bellows 390′ may beindependently biased, as with diaphragm 390, or include and inherentbias. In either case the bellows 390′ will be normally biased in theoutwardly extended orientation, as represented in FIG. 31 and becollapsible upon the increase in pressure within the pressure chamber364, due to the inflow of inflating air.

In addition, an outlet port of the casing 362 may be in the form of amale luer type connector 374 including an interior lumen 376. As setforth in greater detail hereinafter the connector structure 374 and theinterior lumen 376 may at least partially define a path of fluid flow ofthe cuff inflating air. More specifically, the inflating air passes fromthe pressure chamber 364 into a connecting collar or connector 80associated with the inflating lumen 15 and hub 82. As clearlyrepresented in the embodiment of FIG. 2, the connector 80, hub 82 andinflating lumen 15 are connected to or otherwise directly associatedwith the retaining cuff as described above. Further, the connector 80may be in the form of a female luer connector and once disposed insealing or mating engagement with the male luer type connecting member374, serves to at least partially define a path of fluid flow from thecasing 362 through the inflating lumen 15 to the retaining cuff. As alsoemphasized in the above noted embodiments, this established path offluid flow will result an equal pressure within the pressure chamber 364and the inflated retaining cuff. As a result, a monitoring of thepressure of the inflated retaining cuff can be accurately monitoredthrough the provision of an indicator assembly 310.

Further with regard to the embodiments of FIGS. 23, 24 and 31 theindicator assembly 310 and is directly associated with the operativefeatures of the diaphragm 390. As described above with the embodimentsof FIG. 1A and 1B, the casing 362 includes a window 158 and a pluralityof pressure indicating indicia formed on the exterior surface thereof.The diaphragm 390 and the bellows 390′ are cooperatively structured toserve as part of the indicator assembly 310 thereby providing anindication of the pressure within the pressure chamber 364 and as aresult the substantially equivalent pressure within the retaining cuff.Therefore the substantially equivalent pressures within the pressurechamber 364 and the retaining cuff is due to the fluid communicatinginterconnection between the casing 362 and the inflating lumen 15, byvirtue of the connector 80 and connector 374 being disposed in matingengagement with one another, as also described above.

Another structural and operative feature of the additional preferredembodiment of FIGS. 23-31 includes the provision of an adaptor assembly400. Moreover, the adaptor assembly 400 is structured to define a singleuse connection between the retaining cuff, via the connector 80 of theinflating lumen 15, as represented in FIG. 2. Moreover, the adaptorassembly 400 includes a housing 406 having an at least partially hollowinterior and an at least partially outer open end 408. The opposite end408′ of the adaptor or housing 406 may be removably or fixedly connectedto the casing 362. In addition, the outlet port connector 374 of thecasing 362 is received within the interior of the adaptor housing 406 incooperative relation with a restrictor 412. As set forth above, in atleast one embodiment of the present invention, the outlet portcomprising the connector 374 may be in the form of a male luer connectorstructured to establish a path of fluid flow with the connector 80 ofthe inflating lumen 15. As also indicated the connector 80 may be in theform of a female luer connector so as to establish sealing engagementwith the outlet port connector 374 in the form of a male luer connector.As a result, mating engagement (see FIG. 29) between the correspondingluer connectors of the outlet port connector 374 and connector 80collectively define a luer type coupling or fastener and the path offluid from the interior of the casing 360 into and through the inflatinglumen 15.

Additional features of the adaptor assembly 400 include a restrictor 412movable within the interior of the adaptor housing 406. As such therestrictor 412 preferably, but not necessarily, at least partiallysurrounds the outlet port connector 374 and is disposed in at leastpartially receiving relation to the 80 as clearly represented.Cooperative structuring between the restrictor 412 and the adaptorhousing 406, including interior portions thereof, serve to facilitatethe movement of the restrictor 412 between a receiving position; asrepresented in FIGS. 25 and 28, an operative position; as represented inFIGS. 26 and 29 and an inoperative position; as represented in FIGS. 27and 30. As also schematically represented in FIGS. 28-29, the restrictor412 may be movably forced from the receiving position of FIGS. 25 and 28into the operative position of FIGS. 26 and 29 by a directed force 413sufficient to accomplish the connection of the connector 80 to theoutlet port or male luer connector 374. The inwardly or axially directedforce 413 is exerted on the restrictor 412 by a forced movement orpositioning of the connector 80 of the lumen 15, while engaging acorresponding portion or end of the adaptor housing 406. As set forthabove, once in the operative position of FIGS. 26 and 29, the connector80 is disposed in sealing or mating engagement with the outlet portconnector 374. The aforementioned path of fluid flow is therebyestablished between the lumen 15, into the interior of the casing 362and eventually to the retaining cuff.

Additional structural and operative features associated with the adaptorassembly 412 include the provision of an orienting assembly connected toor mounted on both interior portions of the adaptor housing 406 andportions of the restrictor 412. More specifically, the orientingassembly includes a track structure generally indicated as 420 formed oninterior wall surfaces of the housing 406 or other appropriate portionsthereof. The track structure 420 preferably includes a curved and/orangular configuration and may include a curved and/or angular rampmember 422. In addition, the orienting assembly includes at least onebut preferably a plurality of orienting members 424 connected to aremainder of the restrictor assembly 412 and extending at leastpartially outwardly there from. Additionally, in at least one structuralmodification or additional embodiment, the orienting assembly includesone or more orienting members 424. The orienting members 424 preferably,but not necessarily, are formed of a flexible material having sufficientresiliency to be normally biased outwardly from the remainder of therestrictor 412 into engagement with the track structure 420.

The one or more orienting members 424 will be disposed into movableengagement with at least a portion of the track structure 420 and will“follow” the curved or angular path of the portion of the trackstructure 420 which the orienting members 424 engage. As such, a forcedpositioning of the restrictor 412 by an inward and/or axial movement 413of the connector 80 (or relative axial movement therebetween) willresult in the axial travel of the restrictor 412 from the receivingposition to the operative position and a concurrent predeterminedreorientation of the restrictor 412. Such a predetermined reorientationof the restrictor 412 concurrently to its axial movement within theinterior of the housing 406 is caused by the movable interaction betweenand the “following” of the one or more orienting members 424 along thetrack assembly 420. As clearly indicated, the connection of theorienting members 424 with the remainder of the restrictor 412 willresult in a corresponding “reorientation” of the remainder of therestrictor 412 as it is forced from the receiving position into theoperative position. Moreover, it is to be noted that the disposition ofthe track structure 420 extends about and along potions of the interiorsurface of the adaptor housing 406. This disposition as well as thecurved and/or angular configuration of at least portions of trackassembly 420 and/or the provision of one or more ramps 422 will cause arotation and/or a “rotational reorientation” of the restrictor 412within the interior of the housing 406, concurrently to its travel fromthe receiving position to the operative position. Such a rotationalreorientation is further due to the interaction of the one or moreorienting members 424 with the track structure 420.

As also represented in FIGS. 23-31, the adaptor assembly 400 includes abiasing structure 429 disposed within the interior of the housing 406 inbiasing relation or engagement with the restrictor 412. The dispositionof the biasing structure 429 is such as to normally bias the restrictor412 outwardly or towards the open end 408 of the adaptor housing 406 andinto the inoperative position, as represented in FIGS. 27 and 30.Accordingly, the removal or detachment of the connector 80 from thecasing 362 and adaptor housing 406, as indicated by directional arrow413′ in FIG. 30, will result in a lessening or removal of the axialforce 413. In turn this will allow the biasing structure 429 to forcethe restrictor 412 into the aforementioned inoperative position, asrepresented in FIGS. 27 and 30. Further facilitating the disposition ofthe restrictor 412 in the inoperative position is the continued movableengagement of the one or more restrictors 424 with a correspondingportion of the track assembly 420 on interior portions of the housing406. As such, the corresponding portions of the track assembly 420 willallow the one or more orienting members 424 to be unobstructed in thetravel of the restrictor 412 within the housing, from the operativeposition of FIG. 29 into the inoperative position of FIG. 30.

Additional structural features which may be associated with one or morepreferred embodiments of the adaptor assembly 400 include the provisionof a retaining structure 430. The retaining structure 430 is alsopreferably formed on the interior of the housing 406. The retainingstructure 430 may comprise a plurality of independent and/or spacedapart recesses or alternatively an annular, semi-annular or otherappropriately configured groove or recess, as represented in at leastFIGS. 29 and 30. Moreover, the retaining structure 430 may be a part ofthe track structure 420 and as such may be disposed in communicatingrelation with a linear or other appropriately configured track segment423. Therefore, upon release of the inwardly directed force 413, such asat 413′, exerted on the restrictor 412 by the connector 80, the one ormore orienting members 424 may travel along the track segment(s) 432until the distal ends or projected portions 424′ engage or are at leastpartially disposed in a retained relation with the retaining structure430.

When so positioned, the structured disposition or inherent outwardbiasing feature of the orienting members 424 will cause the distal ends424′ thereof to be substantially fixed within or relative to theretaining structure 430. Therefore, when the restrictor 412 is in theinoperative position, it is disposed in obstructing relation to theconnector 80, thereby preventing or restricting the forced positioningof the restrictor 412 by the connector 80 into the operative position.Moreover, the obstructing position of the restrictor 412 will restrictthe connector 80 from entering the adaptor housing 406 to a positionwhere the connector 80 can establish the aforementioned path of fluidflow with the outlet port or male connector 374. Therefore, the adaptorassembly 400 of the present invention, through the provision of theretaining structure 430 and the interaction thereof with the one or moreorienting members 424 can be said to define a single use connectionbetween the retaining cuff via the connector 80 of the inflating lumen15.

However, it is again emphasized that the adaptor assembly 400 includingthe provision of the retaining structure 430 and the interaction thereofwith the orienting assembly, as described herein, could be effective indefining a single use connection between different but cooperativelystructured medical devices especially, but not limited to, where one ofthe devices includes a luer type connector.

As represented in FIGS. 25-27 other features associated with therestrictor 412 include it being color coded so as to provide a clearindication that the adaptor assembly 400 is in fact a single use device.Such color coding may also be used independently of or in combinationwith appropriate indicia to provide a further visual indication that theadaptor assembly has been previously used and is no longer usable.

Since many modifications, variations and changes in detail can be madeto the described preferred embodiment of the invention, it is intendedthat all matters in the foregoing description and shown in theaccompanying drawings be interpreted as illustrative and not in alimiting sense. Thus, the scope of the invention should be determined bythe appended claims and their legal equivalents.

Now that the invention has been described,

1. An assembly structured to inflate and monitor pressure within aretaining cuff of a medical device, said assembly comprising: a casingincluding an interior pressure chamber and an outlet port disposable influid communication with the retaining cuff, said casing structured forconnecting an inflating fluid source in fluid communication with saidpressure chamber, an adapter disposed on said casing and structured todefine a single use connection between said casing and a connector tothe retaining cuff, said adapter including a restrictor movably disposedtherein in receiving relation to the connector, said restrictor movablewithin said adapter between a receiving position, an operative positionand an inoperative position, said operative position comprising a pathof fluid flow from said casing to the retaining cuff via said outletport and the connector to the retaining cuff, and said inoperativeposition comprising said restrictor disposed in obstructing relation tothe connector and an establishment of said path of fluid flow.
 2. Anassembly as recited in claim 1 wherein said inoperative position furthercomprises a substantially fixed disposition of said restrictor in saidobstructing relation to the connector.
 3. An assembly as recited inclaim 2 wherein said fixed disposition of said restrictor is at leastpartially defined by a retaining engagement of said restrictor withinterior portions of said adaptor.
 4. An assembly as recited in claim 1further comprising an orienting assembly at least partially defined bycooperative structuring of said restrictor and said adaptor; saidorienting assembly structured for reorientation of said restrictorconcurrently to and independently of movement of said restrictor betweensaid receiving and operative positions.
 5. An assembly as recited inclaim 4 wherein said cooperative structuring comprises at least aportion of said restrictor disposed in movable engagement with interiorportions of said adaptor at least during movement said restrictorbetween said receiving and operative positions.
 6. An assembly asrecited in claim 5 wherein said interior portions are disposed andconfigured to at least partially define a rotational reorientation ofsaid restrictor relative to said adaptor.
 7. An assembly as recited inclaim 4 wherein said orienting assembly comprises a track structuredisposed within said adaptor and at least one orienting member connectedto said restrictor and movable therewith; said one orienting memberdisposed in engaging relation with said track structure and movablealong at least a portion of a length of said track structure.
 8. Anassembly as recited in claim 7 wherein said track structure comprises anat least partially curved configuration.
 9. An assembly as recited inclaim 7 wherein said track structure includes an angularly oriented rampportion disposed in engaging relation with said orienting memberconcurrent to movement of said restrictor between said receiving andoperative positions.
 10. An assembly as recited in claim 7 wherein saidtrack structure and said one orienting member are cooperativelystructured for rotational reorientation of said restrictor concurrentlyto axial movement thereof, relative to said adaptor, between saidreceiving and operative positions.
 11. An assembly as recited in claim 7further comprising a retaining structure disposed in engageable relationwith said one orienting member and cooperatively structured therewith tofixedly retain said restrictor in said inoperative position.
 12. Anassembly as recited in claim 11 wherein said track structure and saidone orienting member are cooperatively disposed and structured forrotational reorientation of said retractor concurrently to axialmovement thereof, within said adaptor, between said receiving andoperative positions.
 13. An assembly as recited in claim 12 wherein saidone orienting member is at least partially formed of a flexiblematerial; said flexible material including sufficient resiliency tonormally bias said orienting member into said engaging relation withsaid track structure.
 14. An assembly as recited in claim 7 wherein saidorienting assembly comprises a plurality of orienting members eachconcurrently disposable in movable engagement with said track structureand cooperatively structured therewith for rotational reorientation ofsaid restrictor concurrently to axial movement thereof between saidreceiving and operative positions.
 15. An assembly as recited in claim 1further comprising a biasing member disposed within said adaptor andstructured to normally bias said restrictor into said inoperativeposition.
 16. An assembly as recited in claim 15 wherein said restrictorand said housing are cooperatively structured to force disposition ofsaid restrictor from said receiving position to said operative positionupon an insertion of the connector into said adaptor.
 17. An assembly asrecited in claim 1 wherein said adaptor and said restrictor arecooperatively structured to concurrently receive a first luer fastenerdefining the connector and a second luer fastener defining said outletport; said operative position comprising an operative connection of saidfirst and second luer fasteners and an establishment of said path offluid flow.
 18. An assembly as recited in claim 1 further comprising anindicator assembly movably disposed on said casing in fluidcommunication with said pressure chamber, said indicator assemblyincluding an indicator member variably positionable on said casingdependent on and indicative of existing pressure within said pressurechamber and the retaining cuff.
 19. An assembly structured to inflateand monitor pressure within a retaining cuff of a medical device, saidassembly comprising: a casing including an interior pressure chamber andan outlet port disposable in fluid communication with the retainingcuff, said casing structured for connecting an inflating fluid source influid communication with said pressure chamber, an adapter disposed onsaid casing and structured to define a single use connection betweensaid casing and a connector to the retaining cuff, said adapterincluding a restrictor movably disposed therein in receiving relation tothe connector, said restrictor movable within said housing between areceiving position, an operative position and an inoperative position,an orienting assembly disposed within said housing and structured for apredetermined reorientation of said restrictor concurrently toindependent movement of said restrictor at least between said receivingan operative positions, said operative position at least partiallydefining a path of fluid flow between said casing and the retaining cuffthrough said outlet port and the connector, said inoperative positioncomprising said restrictor disposed in obstructing relation to entry ofthe connector into said operative position, and a retaining structuredisposed within said adaptor in engageable relation with said restrictorand cooperatively structured therewith to fixedly dispose saidrestrictor in said inoperative orientation.
 20. An assembly as recitedin claim 19 wherein said orienting assembly comprises a track structureand at least one orienting member cooperatively structured forrotational reorientation of said retractor concurrently to axialmovement thereof between said receiving and operative positions.
 21. Anassembly as recited in claim 20 wherein said track structure is disposedwithin said adaptor and said at least one orienting member is connectedto said restrictor and movable therewith; said one orienting memberdisposed in engaging relation with said track structure and movablealong at least a portion thereof concurrently to said restrictor movingbetween said receiving position and said operative position.
 22. Anassembly as recited in claim 19 further comprising an indicator assemblymovably disposed and visually accessible on said casing in fluidcommunication with said pressure chamber, said indicator assemblyincluding an indicator member variably positionable on said casingdependent on and indicative of existing pressure within said pressurechamber and the retaining cuff.
 23. An adapter assembly structured toestablish a one time connection of a port of a first medical device to asecond medical device, said adapter assembly comprising: a housingconnected to the second medical device, a restrictor disposed withinsaid housing in receiving relation to the port of the first medicaldevice, said restrictor movable within said housing between a receivingposition and an operative position, said operative position at leastpartially defining a path of fluid flow from the port of the firstmedical device to the second medical device, said restrictorcooperatively structured with said housing for further movement into aninoperative position, and said inoperative position comprising saidrestrictor at least partially disposed within said housing inobstructing relation to the port of the first medical device.